The present invention relates to methods for blocking tubular anatomical structures. In particular, the present invention relates to methods for ligating the fallopian tube to achieve sterilization. The present invention pertains in addition to devices for performing tubal ligations.
Occlusion of tubular anatomical structures is desirable for various medical treatments. One important application of occlusion techniques is blockage of the fallopian tubes in the female or vas deferens in the male to achieve sterilization and prevent undesired pregnancies.
Various methods for producing occlusion or blockage of tubular anatomical structures have been considered for contraceptive purposes. A commonly used method for blocking the fallopian tube is to tie off or clamp the fallopian tube. The tube may be tied in two locations and the intermediate portion of tube removed. A similar result may be obtained by grasping and folding over a portion of the tube and tying off a loop of tube that does not communicate with the remainder of the tube. The folded segment of tube may be blocked by a loop of suture material, a elastic ligating band or O-ring, or a clamp. Access to the fallopian tube is usually gained through endoscopic surgery, either through the abdominal wall or, less commonly, through the wall of the vagina. Such methods are less invasive than conventional surgical methods, but still have an undesirably high risk of infection and tissue damage, and are accompanied by an undesirable recovery time and level of discomfort.
To eliminate the need for endoscopic or other, more invasive, surgery, a number of approaches have been devised for blocking the lumen of the fallopian tube after accessing the interior of the fallopian tube by inserting a catheter into the lumen of the tube via the vagina and uterus.
One approach is to block the fallopian tube by injecting an adhesive or sealant, typically a polymeric material, into the fallopian tube to form a plug. Another approach is to insert a pre-formed occlusive device or plug into the lumen of the fallopian tube or the utero-tubal junction. However, either type of plug may separate or dislodge from the wall of the fallopian tube, resulting in unreliable or impermanent blockage.
Another approach for blocking the fallopian tube or other tubular anatomic structures is to induce the formation of sclerosis or scar tissue to block the tube. Tissue damage may be induced chemically or thermally. However, this method is relatively difficult to accomplish successfully and requires skilled personnel and specialized equipment, making it unsuited for use in certain settings.
Improvements over the prior art desirably will provide a method and system for applying a ligating structure to the interior of a tubular anatomical structure. Desirable improvements will cause a reliable occlusion of a tubular anatomical structure. Such occlusion of a tubular anatomical structure desirably is permanent in certain applications, such as in reproductive contraception. An inexpensive method for occluding a tubular anatomical structure is also desired. An improvement may provide a partially or completely disposable device for performing occlusion of a tubular anatomical structure. It would be a further advance to provide an improved method for performing tubal ligations which requires only minimally invasive surgery, thereby reducing damage to vascular and reproductive tissues and reducing post-surgical discomfort and recovery time. A method for performing tubal ligations which further reduces the risk of infection is also desirable.
In accordance with the invention as embodied and broadly described herein, a device is provided for applying ligating bands to tissue in the interior of a tubular anatomical structures. The invention also includes a method of using the device.
The device may be embodied as a surgical instrument for contraception of female reproduction by occluding the fallopian tubes. Such a device has a proximal and a distal end, the device being generally elongated and configured to permit insertion of the distal end into a fallopian tube via the vagina and uterus, while the device is held and controlled external to the patient, at the proximal end.
The female contraceptive device generally includes an elongated tube having a central, longitudinally extending lumen and a grasper carried on an end of an elongated member slidably disposed in the lumen. The grasper is capable of extending distally from the distal end of the tube, grasping tissue on the interior of a fallopian tube, and retracting proximally with the grasped tissue. Structure, including active mechanisms, may be provided at the distal end of the tube to assist in creating a circumferential fold, or an invagination of the fallopian tube, forming a tissue bundle or peduncle. One or more ligating bands are typically carried near the distal end of the tube. A ligating band may be released from the distal end of the tube to contract as a sphincter about the tissue bundle and thereby occlude a passageway through the fallopian tube. One way to release a ligating band is by driving the band distally, with a distal end of a sleeve slidably deployed around the tube, moving the band off from band supporting structure.
The proximal end of the device can be provided with a handle or base, and a number of controls thereon for controlling extension and retraction of the grasper with respect to the tube, actuation of the grasper, and release of ligating bands onto a tissue bundle, among other operations. The device may be provided with a current source for supplying current to cauterize tissue held by the grasper, or to separate the grasper from an extension member. The device may also be provided with an additional lumen for delivering drugs or other compounds, such as antibiotics, topical anesthetics, or chemical cauterizing agents, in the vicinity of the ligation.
A method of using the device includes the steps of inserting the distal end of the device into a tubular anatomical structure, causing the grasper to extend distally out of the tube, grasping tissue in the interior of the tubular anatomical structure with the grasper, retracting the grasper proximally, forming an inner tissue bundle, and releasing a ligating band from the distal end of the tube to contract as a sphincter around the inner tissue bundle. The method may further include the steps of withdrawing the device to a new position within the tubular anatomical structure and repeating the preceding steps to apply one or more additional ligating bands.